EP2299992A4 - Process for preparing and drying solid rasagiline base - Google Patents

Process for preparing and drying solid rasagiline base

Info

Publication number
EP2299992A4
EP2299992A4 EP09767090.5A EP09767090A EP2299992A4 EP 2299992 A4 EP2299992 A4 EP 2299992A4 EP 09767090 A EP09767090 A EP 09767090A EP 2299992 A4 EP2299992 A4 EP 2299992A4
Authority
EP
European Patent Office
Prior art keywords
preparing
drying solid
rasagiline base
solid rasagiline
base
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09767090.5A
Other languages
German (de)
French (fr)
Other versions
EP2299992A2 (en
Inventor
Anton Frenkel
Ronen Ben-David
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Publication of EP2299992A2 publication Critical patent/EP2299992A2/en
Publication of EP2299992A4 publication Critical patent/EP2299992A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C211/00—Compounds containing amino groups bound to a carbon skeleton
    • C07C211/33—Compounds containing amino groups bound to a carbon skeleton having amino groups bound to carbon atoms of rings other than six-membered aromatic rings
    • C07C211/39—Compounds containing amino groups bound to a carbon skeleton having amino groups bound to carbon atoms of rings other than six-membered aromatic rings of an unsaturated carbon skeleton
    • C07C211/41—Compounds containing amino groups bound to a carbon skeleton having amino groups bound to carbon atoms of rings other than six-membered aromatic rings of an unsaturated carbon skeleton containing condensed ring systems
    • C07C211/42—Compounds containing amino groups bound to a carbon skeleton having amino groups bound to carbon atoms of rings other than six-membered aromatic rings of an unsaturated carbon skeleton containing condensed ring systems with six-membered aromatic rings being part of the condensed ring systems
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2602/00—Systems containing two condensed rings
    • C07C2602/02—Systems containing two condensed rings the rings having only two atoms in common
    • C07C2602/04—One of the condensed rings being a six-membered aromatic ring
    • C07C2602/08—One of the condensed rings being a six-membered aromatic ring the other ring being five-membered, e.g. indane

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP09767090.5A 2008-06-19 2009-06-19 Process for preparing and drying solid rasagiline base Withdrawn EP2299992A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13248708P 2008-06-19 2008-06-19
PCT/US2009/003670 WO2009154777A2 (en) 2008-06-19 2009-06-19 Process for preparing and drying solid rasagiline base

Publications (2)

Publication Number Publication Date
EP2299992A2 EP2299992A2 (en) 2011-03-30
EP2299992A4 true EP2299992A4 (en) 2015-10-21

Family

ID=41431882

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09767090.5A Withdrawn EP2299992A4 (en) 2008-06-19 2009-06-19 Process for preparing and drying solid rasagiline base

Country Status (13)

Country Link
US (2) US7968749B2 (en)
EP (1) EP2299992A4 (en)
JP (1) JP2011524907A (en)
CN (1) CN102065853A (en)
AU (1) AU2009260728B2 (en)
BR (1) BRPI0909997A2 (en)
CA (1) CA2727017A1 (en)
EA (1) EA021472B1 (en)
IL (1) IL209134A0 (en)
MX (1) MX2010013875A (en)
NZ (1) NZ589547A (en)
WO (1) WO2009154777A2 (en)
ZA (1) ZA201008755B (en)

Families Citing this family (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006014973A2 (en) * 2004-07-26 2006-02-09 Teva Pharmaceutical Industries, Ltd. Pharmaceutical dosage forms including rasagiline
CN101098685A (en) * 2004-11-24 2008-01-02 特瓦制药工业有限公司 Rasagiline orally disintegrating compositions
EP1991214B1 (en) * 2006-02-21 2015-08-05 Teva Pharmaceutical Industries, Ltd. Use of rasagiline for the treatment of multiple system atrophy
CN101442997B (en) * 2006-04-03 2012-11-14 泰华制药工业有限公司 Use of rasagiline for the treatment of restless legs syndrome
EP1892233A1 (en) 2006-08-18 2008-02-27 Ratiopharm GmbH New salts of the active component rasagiline
AU2007334428B2 (en) * 2006-12-14 2014-05-29 Teva Pharmaceutical Industries, Ltd. Crystalline solid rasagiline base
EP1987816A1 (en) * 2007-04-30 2008-11-05 Ratiopharm GmbH Adsorbate of a rasagiline salt with a water-soluble inactive ingredient
EP2194780A4 (en) * 2007-09-05 2010-10-27 Teva Pharma Method of treating glaucoma using rasagiline
US8188149B2 (en) * 2007-09-17 2012-05-29 Teva Pharmaceutical Industries, Ltd. Use of R(+)-N-propargy1-1-aminoindan to treat or prevent hearing loss
CN101909438A (en) * 2008-01-11 2010-12-08 泰华制药工业有限公司 Rasagiline formulations, their preparation and use
EP2285214B1 (en) * 2008-06-10 2012-05-16 Teva Pharmaceutical Industries Ltd. Rasagiline soft gelatin capsules
MX2010013766A (en) * 2008-06-13 2011-03-15 Teva Pharmaceutical Ind Ltd Star Rasagiline for parkinson's disease modification.
WO2009154782A1 (en) * 2008-06-19 2009-12-23 Teva Pharmaceutical Industries, Ltd. Process for purifying rasagiline base
US20100189788A1 (en) * 2009-01-23 2010-07-29 Teva Pharmaceutical Industries, Ltd. Delayed release rasagiline base formulation
EP2451771B1 (en) 2009-07-09 2014-06-18 Ratiopharm GmbH Salts of rasagiline and pharmaceutical preparations thereof
EP2485722A1 (en) * 2009-10-09 2012-08-15 Teva Pharmaceutical Industries, Ltd. Use of rasagiline for the treatment of progressive supranuclear palsy
CN102048717B (en) 2009-10-29 2014-02-19 重庆医药工业研究院有限责任公司 Stable rasagiline composition
US20110152381A1 (en) * 2009-12-22 2011-06-23 Anton Frenkel 3-keto-n-propargyl-1-aminoindan
SG184547A1 (en) * 2010-04-30 2012-11-29 Teikoku Pharma Usa Inc Propynylaminoindan transdermal compositions
JP2013537530A (en) 2010-07-27 2013-10-03 テバ ファーマシューティカル インダストリーズ リミティド Rasagiline citrate dispersion
JP2013533287A (en) 2010-07-27 2013-08-22 テバ ファーマシューティカル インダストリーズ リミティド Use of rasagiline for the treatment of olfactory dysfunction
KR20140090996A (en) 2011-10-10 2014-07-18 테바 파마슈티컬 인더스트리즈 리미티드 R(+)-n-formyl-propargyl-aminoindan
EP2766004A4 (en) 2011-10-10 2015-04-22 Teva Pharma R(+)-n-methyl-propargyl-aminoindan
US9913812B2 (en) 2011-11-09 2018-03-13 Teikoku Pharma Usa, Inc. Methods for the treatment of skin neoplasms
MX343986B (en) 2012-03-21 2016-12-01 Synthon Bv Stabilized pharmaceutical compositions comprising rasagiline salts.
AR092168A1 (en) 2012-08-17 2015-03-25 Teva Pharma PARENTERAL FORMULATIONS OF RASAGILINA
US9227911B2 (en) * 2012-08-31 2016-01-05 Sumitomo Chemical Company, Limited Method for producing (R)-1, 1, 3-trimethyl-4-aminoindane
JP6050896B2 (en) 2012-11-02 2016-12-21 テイコク ファーマ ユーエスエー インコーポレーテッド Propinylaminoindan transdermal composition
US9151660B2 (en) * 2013-05-22 2015-10-06 Professional Compounding Centers Of America (Pcca) Method for validation of pharmaceutical formulation composition weight

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0436492A2 (en) * 1990-01-03 1991-07-10 Teva Pharmaceutical Industries Limited R-Enantiomer of N-propargyl-1-aminoindan, its preparation and pharmaceutical compositions containing it
WO2007061717A2 (en) * 2005-11-17 2007-05-31 Teva Pharmaceutical Industries, Ltd. Methods for isolating propargylated aminoindans
WO2008076348A1 (en) * 2006-12-14 2008-06-26 Teva Pharmaceutical Industries, Ltd. Crystalline solid rasagiline base

Family Cites Families (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5744500A (en) 1990-01-03 1998-04-28 Teva Pharmaceutical Industries, Ltd. Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof
IL99759A (en) 1991-10-16 1997-06-10 Teva Pharma Mono-fluorinated derivatives of n-propargyl-1-aminoindan, their preparation and pharmaceutical compositions containing them
IL115357A (en) 1995-09-20 2000-01-31 Teva Pharma Stable compositions containing N-propargyl-1-aminoindan and polyhydric alcohols
IL118836A (en) 1996-07-11 2001-01-11 Teva Pharma Pharmaceutical compositions comprising s-(-)-n-propargyl-1-aminoindan
IL130528A (en) 1996-12-18 2004-12-15 Teva Pharma Aminoindan derivatives, pharmaceutical compositions comprising them and uses thereof
EP2526944B1 (en) 2002-11-15 2016-06-01 Teva Pharmaceutical Industries Limited Use of rasagiline with or without riluzole to treat amyotrophic lateral sclerosis
WO2006014973A2 (en) 2004-07-26 2006-02-09 Teva Pharmaceutical Industries, Ltd. Pharmaceutical dosage forms including rasagiline
CN101098685A (en) 2004-11-24 2008-01-02 特瓦制药工业有限公司 Rasagiline orally disintegrating compositions
JP5738509B2 (en) 2005-02-23 2015-06-24 テバ ファーマシューティカル インダストリーズ リミティド Rasagiline formulation with improved content uniformity
US7572834B1 (en) 2005-12-06 2009-08-11 Teva Pharmaceutical Industries, Ltd. Rasagiline formulations and processes for their preparation
EP1991214B1 (en) 2006-02-21 2015-08-05 Teva Pharmaceutical Industries, Ltd. Use of rasagiline for the treatment of multiple system atrophy
CN101032474B (en) * 2006-03-06 2011-02-16 重庆医药工业研究院有限责任公司 Rasagiline transparent patch for curing and preventing neurological diseases and the preparing method thereof
CN101442997B (en) 2006-04-03 2012-11-14 泰华制药工业有限公司 Use of rasagiline for the treatment of restless legs syndrome
JP4989153B2 (en) * 2006-08-15 2012-08-01 コスモ石油株式会社 Novel crystals of 5-aminolevulinic acid phosphate and method for producing the same
EP1892233A1 (en) 2006-08-18 2008-02-27 Ratiopharm GmbH New salts of the active component rasagiline
NZ577623A (en) 2006-12-14 2011-05-27 Teva Pharma Tannate salt of rasagiline
EP1987816A1 (en) 2007-04-30 2008-11-05 Ratiopharm GmbH Adsorbate of a rasagiline salt with a water-soluble inactive ingredient
EP2194780A4 (en) 2007-09-05 2010-10-27 Teva Pharma Method of treating glaucoma using rasagiline
US8188149B2 (en) 2007-09-17 2012-05-29 Teva Pharmaceutical Industries, Ltd. Use of R(+)-N-propargy1-1-aminoindan to treat or prevent hearing loss
KR101523195B1 (en) 2007-12-24 2015-05-27 시플라 리미티드 Process for the synthesis of propargylated aminoindan derivatives
CN101909438A (en) 2008-01-11 2010-12-08 泰华制药工业有限公司 Rasagiline formulations, their preparation and use
EP2271612B1 (en) 2008-03-31 2016-08-10 Actavis Group PTC EHF Rasagiline mesylate particles and process for the preparation thereof
EP2285214B1 (en) 2008-06-10 2012-05-16 Teva Pharmaceutical Industries Ltd. Rasagiline soft gelatin capsules
MX2010013766A (en) 2008-06-13 2011-03-15 Teva Pharmaceutical Ind Ltd Star Rasagiline for parkinson's disease modification.
WO2009154782A1 (en) 2008-06-19 2009-12-23 Teva Pharmaceutical Industries, Ltd. Process for purifying rasagiline base
CN101606923B (en) 2008-06-20 2013-01-09 重庆医药工业研究院有限责任公司 Stable controlled-release rasagiline transdermal patch and preparation method thereof
EA201170181A1 (en) 2008-07-11 2011-08-30 Синтон Бв POLYMORPHIC FORMS OF RAZAGILINA HYDROCHLORIDE
WO2010007181A2 (en) 2008-07-18 2010-01-21 Medichem, S.A. New salt forms of an aminoindan derivative
US20100029987A1 (en) 2008-07-29 2010-02-04 Dipharma Francis S.R.I. Crystalline Form of Rasagiline and Process for the Preparation Thereof
EP2321258A1 (en) 2008-07-30 2011-05-18 Generics [UK] Limited Polymorphic form of rasagiline mesylate
EP2181980A1 (en) 2008-10-28 2010-05-05 Chemo Ibérica, S.A. A process for the preparation of (R)-1-aminoindanes
DE102008064061A1 (en) 2008-12-19 2010-06-24 Ratiopharm Gmbh Solid composition with the active ingredient rasagiline
US20100189788A1 (en) 2009-01-23 2010-07-29 Teva Pharmaceutical Industries, Ltd. Delayed release rasagiline base formulation
EP2451771B1 (en) 2009-07-09 2014-06-18 Ratiopharm GmbH Salts of rasagiline and pharmaceutical preparations thereof
WO2011009873A2 (en) 2009-07-20 2011-01-27 Medichem, S.A. New form of an aminoindan mesylate derivative
WO2011010324A1 (en) 2009-07-23 2011-01-27 Alkem Laboratories Ltd. Oral pharmaceutical composition of rasagiline and process for preparing thereof
EP2485722A1 (en) * 2009-10-09 2012-08-15 Teva Pharmaceutical Industries, Ltd. Use of rasagiline for the treatment of progressive supranuclear palsy
US20110152381A1 (en) * 2009-12-22 2011-06-23 Anton Frenkel 3-keto-n-propargyl-1-aminoindan

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0436492A2 (en) * 1990-01-03 1991-07-10 Teva Pharmaceutical Industries Limited R-Enantiomer of N-propargyl-1-aminoindan, its preparation and pharmaceutical compositions containing it
US5532415A (en) * 1990-01-03 1996-07-02 Teva Pharmaceutical Industries Ltd. R-enantiomer of N-propargyl-1-aminoindan, salts, compositions and uses thereof
WO2007061717A2 (en) * 2005-11-17 2007-05-31 Teva Pharmaceutical Industries, Ltd. Methods for isolating propargylated aminoindans
WO2008076348A1 (en) * 2006-12-14 2008-06-26 Teva Pharmaceutical Industries, Ltd. Crystalline solid rasagiline base

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "European Medicines Agency ICH Topic Q 6 A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Step 5 NOTE FOR GUIDANCE SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICA", 1 January 2006 (2006-01-01), pages 1 - 32, XP055211303, Retrieved from the Internet <URL:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002823.pdf> [retrieved on 20150904] *
FRANCIS X. MCCONVILLE: "Tips for Drying Active Pharmaceutical Ingredients", PROCESS HEATING, 3 November 2007 (2007-11-03), XP055178444, Retrieved from the Internet <URL:http://www.process-heating.com/articles/print/86271-tips-for-drying-active-pharmaceutical-ingredients> [retrieved on 20150323] *

Also Published As

Publication number Publication date
ZA201008755B (en) 2012-02-29
US20090318564A1 (en) 2009-12-24
IL209134A0 (en) 2011-01-31
WO2009154777A3 (en) 2010-05-06
CN102065853A (en) 2011-05-18
WO2009154777A2 (en) 2009-12-23
US7968749B2 (en) 2011-06-28
EA021472B1 (en) 2015-06-30
EA201170053A1 (en) 2011-08-30
BRPI0909997A2 (en) 2015-10-27
AU2009260728B2 (en) 2015-01-29
WO2009154777A4 (en) 2010-07-01
NZ589547A (en) 2013-03-28
CA2727017A1 (en) 2009-12-23
EP2299992A2 (en) 2011-03-30
AU2009260728A1 (en) 2009-12-23
JP2011524907A (en) 2011-09-08
US8163960B2 (en) 2012-04-24
US20110281953A1 (en) 2011-11-17
WO2009154777A9 (en) 2011-01-27
MX2010013875A (en) 2011-01-20

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